9 дней назад
Associate Director or Senior Manager, Value Evidence and Outcomes (VEO)
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Associate Director or Senior Manager, Value Evidence and Outcomes (VEO) (Biopharma/HEOR): Planning and executing Japan evidence-generation strategies, including health technology assessments, clinical and observational studies, real-world evidence, and cost-effectiveness analyses, with an accent on resolving local unmet medical needs and supporting Insmed portfolio strategies. Focus on designing and managing complex studies, developing evidence plans, coordinating cross-functional and external stakeholders, and delivering compliant data for publications, pricing, and market access.
Location: Tokyo office, Japan, with weekly flexibility through a hybrid work environment. Occasional domestic and global travel of up to 30% is required.
Company
is a global biopharmaceutical company developing treatments intended to improve the lives of patients with serious and rare diseases.
What you will do
- Identify data gaps and resolvable local unmet medical needs through literature reviews, expert insights, and health technology assessment approaches.
- Lead Japan Value Evidence and Outcomes plans covering efficacy, safety, epidemiology, real-world evidence, patient-reported outcomes, costing, expert consensus, and diagnostic or disease-progression algorithms.
- Plan and manage company-sponsored studies, including interventional and observational research, pre-existing dataset analyses, PMS studies, and PRO studies.
- Ensure study activities comply with GCP, Japan’s Clinical Study Act, ethical guidelines, company policies, SOPs, and applicable publication standards.
- Collaborate with HEOR, Global Medical Strategy, Clinical Development, Commercial, Market Access and Pricing, Patient Advocacy, Publication and Scientific Communications, vendors, and external experts.
- Develop epidemiological data and cost-effectiveness analyses to support clinical trials, Japanese NDA submissions, NHI pricing, market access, publications, and scientific presentations.
Requirements
- Master’s degree in a scientific discipline or equivalent experience; PhD, PharmD, or MD preferred.
- At least 10 years of relevant pharmaceutical or biotechnology experience in a global Japan-based setting, including at least 5 years in evidence-generation strategy, planning, and execution.
- Experience with at least 2 company-sponsored GCP studies, 1 PMS study, 2 PRO studies, and 5 studies using pre-existing datasets.
- Strong knowledge of evidence-generation methods, study design, protocol and SAP development, vendor management, feasibility assessment, expert consultation, budgets, and timelines.
- Native-level Japanese and high-level business English are required.
- For MD holders, an active Japanese medical license is required; foreign medical licenses will not be considered.
Nice to have
- Advanced expertise in pulmonology, bacterial infection, cardiovascular disease, allergy, or immunology.
- HTA certification and experience with Japanese HTA processes, CEA guidelines, cost-effectiveness analysis, or TreeAge.
- Experience in systematic reviews and meta-analyses, HTA research, Delphi consensus development, commercial database studies, or AI-based diagnostic and disease-progression algorithms.
- Board certification in pulmonology, bacterial infection, cardiology, or allergy and immunology.
Culture & Benefits
- Flexible working hours and a hybrid work environment supported by modern collaboration technology and IT services.
- Flexible office seating and open collaboration areas at the Tokyo office.
- Retirement benefits, equity compensation, and employee stock purchase plan participation.
- Internal and external training, LinkedIn Learning, specialized professional development, and AI-supported learning tools.
- Work-life balance support, global recognition programs, and employee resource group activities.
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